Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00401713
First received: November 17, 2006
Last updated: September 21, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to evaluate two surgical interventions in patients with AMD.


Condition Intervention
Age-Related Macular Degeneration
Procedure: Transplantation of autologous RPE
Procedure: Translocation of autologous RPE and Choroid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Visual Acuity: distance and near [ Time Frame: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months ] [ Designated as safety issue: Yes ]
  • FLA [ Time Frame: (preoperatively, 3 months, +/- 12 months after surgery) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • OCT [ Time Frame: (preoperatively, 3 months, 12 months after surgery) ] [ Designated as safety issue: Yes ]
  • UHR OCT [ Time Frame: (after surgery, including silicone oil removal) ] [ Designated as safety issue: Yes ]
  • autofluorescence [ Time Frame: (preoperatively, 3 months, +/- 12 months after surgery) ] [ Designated as safety issue: Yes ]
  • perimetry [ Time Frame: (if feasible) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transplantation of autologous RPE
    RPE cell suspension
    Procedure: Translocation of autologous RPE and Choroid
    RPE patch
Detailed Description:

The Submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with AMD. Transplantation of autologous RPE and translocation of autologous RPE and choroid represent two promising therapeutic interventions in patients with AMD. This prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, FLA) with OCT- and UHR-OCT data.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AMD and submacular cnv
  • non responders to laser treatment or pdt
  • treatment: rpe transplantation or rpe + choroid translocation
  • age over 50 years

Exclusion Criteria:

  • other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
  • optic atrophy
  • unstable glaucoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401713

Locations
Austria
Department of Opthalmology, Rudolf Foundation Clinic
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Principal Investigator: Susanne Binder, MD Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic
  More Information

No publications provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Univ Prof Dr Susanne Binder, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00401713     History of Changes
Other Study ID Numbers: FR-01-CI-2006
Study First Received: November 17, 2006
Last Updated: September 21, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
submacular membrane
transplantation of RPE
translocation of RPE and Choroid

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014